FDA Announces Draft Guidance on Studying Sex Differences in Clinical Trials
January 07, 2025
January 07, 2025
WASHINGTON, Jan. 7 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has made available a draft guidance for industry titled "Study of Sex Differences in the Clinical Evaluation of Medical Products." The guidance highlights the importance of including sufficient numbers of both males and females in clinical trials and non-interventional studies to reflect the prevalence of diseases and conditions that medical products aim to treat.
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The goal is to better understand po . . .